Design Quality Engineer

About the Role

The Design Quality Engineer is responsible for authoring quality deliverables, reviewing, and maintaining the Design history file (DHF) and Risk File records, ensuring compliance with all applicable regulations. The position will work in collaboration with the Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout the product lifecycle activities supporting vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs).

Key Responsibilities

• Support New Product development, design changes, and post-launch activities as the Quality representative on sustaining projects.
• Create Technical records, review and approve Design History File.
• Create and maintain the Risk Management records in alignment with quality system and regulatory requirements, including design and use risk assessments.
• Perform Risk assessment for Quality Events, Nonconformance, and complaints.
• Able to work independently with minimal supervision.
• Can plan and coordinate work according to the project schedule.
• Support inspection readiness by providing risk management/DHF documentation and creating quality plans as needed.
• Support design changes to assess and document risk impact of product and process changes.

Requirements & Tech Stack

• Bachelor’s degree in scientific, engineering, or related field.
• Working knowledge of product development processes.
• Understanding of ISO 13485 quality management system requirements.
• Design controls experience is a plus, including DHF, traceability matrices, V&V documentation, and design review records.
• Experience with medical device risk management (ISO 14971) is a plus.
• Working knowledge of ISO 15189 and ISO 22367 requirements is a plus.
• Ability to adapt to a fast-paced, dynamic work environment with shifting priorities is a plus.
• Experience supporting oncology diagnostic development, LDT workflows, or molecular assay development is a plus.
• Ability to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work performed in a desk or cubicle environment, with occasional exposure to laboratory environments.
• Travel: 10% may be required.